The Doctor of Death is back in the news @BNET http://bit.ly/c2DMnS today. So I though I would bring an disturbing old post back to the top, & add in this important article by Jim Edwards @ BNET as more confirmation of how criminal and corrupt the pharmaceutical industry has become with absolutely no substantive oversight or accountability being brought by our government, the DOJ, or FDA regulators.

Novartis (NVS) gave research funds to a doctor who advocated using the anti-seizure drug Trileptal as an anti-bipolar depression treatment in children — an unapproved use of that drug — the company confirmed to BNET. The doctor, Michael Jay Reinstein, once told a newsletter for parents with bipolar children that “high enough” doses of Trileptal were useful in quelling aggression in bipolar children. Novartis spokesperson Anna Fradle said: "He has done clinical studies on Trileptal on our behalf.

She declined to detail how much money Novartis had paid Reinstein over the years. The use of antidepressants and other pyschiatric drugs in children is controversial. It is not well-established that conditions such as depression, bipolar disorder or mania exist in children, or that if they do the appropriate treatment is a seizure medicine like Trileptal. Yet Johnson & Johnson (JNJ), Shire (SHPGY) and AstraZeneca (AZN) have all funded research by doctors who advocate antidepressants for kids, and so didForest Labs(FRX).

The admission illustrates how a small group of doctors can end up on the payroll of multiple drug companies, triggering illegal “off-label” sales.

Novartis agreed to pay $422 million to end Department of Justice allegations that the company promoted Trileptal for unapproved uses and paid kickbacks to health care providers to induce them to prescribe the drug.

Novartis also instructed its sales representatives to carry “Medical Request Forms” on their sales calls to psychiatrists and use them to “prompt” the psychiatrists to “ask” for information on Trileptal’s off-label uses. While a physician is free to inquire about off-label uses of a drug, a sales representative may not initiate that communication or use a Medical Request Form for such a purpose

…In many cases, the Novartis sales representative even filled out the Medical Request Form in advance of the sales call. They then explained to the psychiatrist that in response to the doctor’s “request,” the company would provide him or her with all the medical data and studies regarding the off-label use. As it turns out, decision-makers at Novartis’ corporate headquarters decided to select out certain positive information in response to the purported requests (consisting mostly of “chart reviews” and single patient or small group studies) and to conceal the negative data and studies suggesting Trileptal is neither safe, nor effective in the treatment of bipolar.

One of the responses Novartis provided to such requests was a summary of research into the use of Trileptal for mania, bipolar and aggression disorders. It mentions a study by “Reinstein et al” in 2002 of patients aged “11-83 years” and another study by Reinstein et al from 2001 in 47 adults. At about that time, Reinstein published a third study of 57 patients on Trileptal vs. patients taking divalproex sodium. And, according to The Bipolar Child, a medical newsletter, Reinstein presented a fourth set of data in 2001 on Trileptal vs. Depakote to the American Psychiatric Association Conference in New Orleans. The Bipolar Child newsletter asked Reinstein about using Trileptal in children. He replied:When the dose gets high enough, the aggression tends to subside.

Reinstein is a controversial figure in psychiatry. He was the subject of Propublica investigation that found he received nearly $500,000 from AstraZeneca (AZN) and became one of the company’s top prescribers of Seroquel, an antipsychotic drug that’s associated with weight gain: “If he is in fact worth half a billion dollars to (AstraZeneca),” the company’s U.S. sales chief wrote in 2001, “we need to put him in a different category.” To avoid scaring Reinstein away, he said, the firm should answer “his every query and satisfy any of his quirky behaviors.”Putting aside its concerns, AstraZeneca would continue its relationship with Reinstein, paying him $490,000 over a decade to travel the nation promoting its best-selling antipsychotic drug, Seroquel. In return, Reinstein provided the company a vast customer base: thousands of mentally ill residents in Chicago-area nursing homes.Reinstein has been criticized for writing prescriptions for an improbably large number of patients.

In 2007 he prescribed various medications to 4,141 Medicaid patients, including more prescriptions for clozapine than were written by all the doctors in Texas put together, Medicaid records show.

Reinstein did not return three messages left for comment at two phone numbers or an email address associated with him.

This, as with other deeply disturbing stories of profiteering, fraud, and medical malpractice which have become far too numerous to even fathom for most average citizens; that do not follow the antics of this modality and industry regularly.

This should be highlighted on every national network news outlet with the Headline "AZ sponsors Doctors of Death in the drugging of America"

This doctor has ties to that big scandal of the AZ sex and corporate espionage fame Wayne McFadden "AZ chief of deception", who worked covering up the side effects of seroquel through ghost writers and burying studies.

This Chicago psychiatrist was featured on advertising pamphlets and spoke to countless doctors as a paid promoter for AZ.

I have to wonder when a billion dollars in legal wrangling will stop protecting AZ from the nasty whole truth being exposed. You might also ask when will the US Attorney General step to the plate and bring criminal charges (with real prison time attached) against these evil entities.

Doctor gives risky drugs at high rate

"In 2007 he prescribed various medications to 4,141 Medicaid patients, including more prescriptions for clozapine than were written by all the doctors in Texas put together, Medicaid records show."

"Records also show he is getting government reimbursement for seeing an improbably large number of patients. Documents filled out by Reinstein suggest that if each of his patient visits lasts 10 minutes, he would have to work 21 hours a day, seven days a week. Reinstein sees 60 patients each day, he wrote in an audit report in 2007."

"Working from a strip-mall office in Uptown, Reinstein says he is psychiatric medical director at 13 nursing facilities, seeing patients with chronic mental illness whom few doctors will accept. Those include people with schizophrenia, who make up the bulk of his practice."

"In written statements to ProPublica and the Tribune, Reinstein said he works long hours seven days a week, as do his four partners, who separately also prescribe clozapine. State records overstate his workload"

"The most gratifying part of my day," he wrote, "(is) when patients reach this level and come to the office!!!"

"Autopsy and court records show that three patients under Reinstein's care died of clozapine intoxication. Alvin Essary died at age 50 at the Somerset Place nursing home on the North Side in 1999. Medical records show that when he died his blood contained five times the toxic level of clozapine."

"Essary's sister, Shirley Palmer, said she can't believe he is still practicing."

"Reinstein said he completes the FDA-mandated blood tests for patients on clozapine but calls them "excessive and severe." Although other psychiatrists said it is crucial to discuss the numerous risks of clozapine with patients, Reinstein said he gives them the product insert -- and hopes they read it."

"Reinstein's troubles were perhaps most dramatic at Maxwell Manor, a South Side nursing home. The Illinois State Police and the U.S. Postal Service began investigating Reinstein in 2000 amid accusations of billing fraud, according to documents obtained through public records requests.

Included in those documents is the account of a Maxwell Manor psychiatric supervisor who said Reinstein heavily promoted Clozaril, the original brand name for clozapine. Deborah Grier told state police investigators that Reinstein had handed out glossy fliers to staff and prescribed the drug to nearly all of his patients.

Grier, who has since died, said Reinstein persuaded some patients to take Clozaril by offering passes to leave the home."

"Another Maxwell Manor worker, Engoyama Fela, told investigators that Reinstein "would not spend more than one minute" with a patient during his rounds, according to a summary of the interview. "Many patients became agitated and rebellious because they knew they needed care and they wanted to talk to Reinstein but were not allowed to," he said.

Fela said Maxwell Manor security staffers were assigned to guard Reinstein when he came to update medical records."

"Barry Miller, the prosecutor overseeing the criminal inquiry, declined to comment. Case records say the matter was referred to Medicare to recover any overpayments. Agency officials declined to comment. Reinstein said he was not sanctioned by Medicare and did not have to reimburse the agency.

Retired state investigator Ray Lewis was unhappy to see the criminal case closed. In a recent interview, he said that if there were one Medicaid fraud case he could revisit, Reinstein's would be it. "I'd investigate it for free," Lewis said.

The agency responsible for investigating physician conduct, the Illinois Department of Financial and Professional Regulation, does not reveal to the public the number of complaints filed against doctors"

On one hand, Chicago psychiatrist Dr. Michael Reinstein was bringing the company a small fortune in sales and was conducting research that made one of its most promising drugs look spectacular.

On the other, some worried that his research findings might be too good to be true.

As Reinstein grew irritated with what he perceived as the company's slights, a top executive outlined the scenario in an e-mail to colleagues.

"If he is in fact worth half a billion dollars to (AstraZeneca)," the company's U.S. sales chief wrote in 2001, "we need to put him in a different category." To avoid scaring Reinstein away, he said, the firm should answer "his every query and satisfy any of his quirky behaviors."

Putting aside its concerns, AstraZeneca would continue its relationship with Reinstein, paying him $490,000 over a decade to travel the nation promoting its best-selling antipsychotic drug, Seroquel. In return, Reinstein provided the company a vast customer base: thousands of mentally ill residents in Chicago-area nursing homes.

During that period, Reinstein also faced accusations that he overmedicated and neglected patients who took a variety of drugs. But his research and promotional work went on, including studies and presentations examining many of the antipsychotics he prescribed on his daily rounds.

The AstraZeneca payments, filed as exhibits in a federal lawsuit, highlight the extent to which a leading drug company helped sustain one of the busiest psychiatrists working in local nursing facilities."

Health professionals who have encountered Reinstein have had similar concerns. When he gave promotional presentations about various medications at Grasmere Place nursing home in Chicago, case manager Staci Burton recalled that she was pleased to get free lunches. But she said she wondered why Reinstein put his patients on twice as many drugs as other psychiatrists who treated residents.

"I was thinking, 'Why are you using so many medications?' " Burton, who worked at the facility from 2004 to 2006, said in an interview. "(His patients) would have symptoms, they'd have all these side effects, and their doctor was not listening."

Psychotropics to lose weight?Chanile Hayes, a South Side resident, says she came under Reinstein's care at a psychiatric hospital after she suffered a nervous breakdown nearly 10 years ago. She found it odd, she said, when Reinstein told her that taking Seroquel would help her lose weight.

"I couldn't understand why he wasn't taking it because he was a plus-sized man himself," said Hayes, now 37. She is one of thousands of people nationwide suing AstraZeneca on allegations it concealed Seroquel's links to weight gain and diabetes.

While she is a plaintiff in New York state, a federal suit is playing out in Orlando, Fla. Reinstein is not a defendant in either case, but Orlando plaintiffs have cast him as a key figure: an influential promoter of Seroquel who was financially backed by AstraZeneca. They allege that Reinstein has claimed that the antipsychotic drug helps patients lose weight.

Hayes said she went from 140 pounds to nearly 300 within two years of taking the drug and later developed diabetes.

Reinstein has done studies, funded by AstraZeneca and two other drugmakers, that found that various medications, including Seroquel, carry an unexpected yet welcome side effect: They help some patients shed pounds.

That claim runs counter to established research that links so-called atypical antipsychotic drugs, such as Seroquel, to considerable weight gain. Drugs in this class, approved for schizophrenia and bipolar disorder, can have other serious side effects that include spastic movement disorders and seizures and can cause premature death among the elderly.

A Seroquel flier dated 1999 features a photograph of Reinstein on the cover. Inside, Reinstein describes one patient losing weight and no longer needing insulin shots because his diabetes had improved so much.

In a 2001 promotional telecast to 5,000 physicians nationwide, Reinstein said he had "jokingly kind of suggested to AstraZeneca" that the drug could be used for "taking away excessive appetite."

"There's actually some nurses in some of our facilities who have actually requested (Seroquel) because they noticed it really did suppress the appetite, and they wanted to lose weight themselves," Reinstein said, according to a transcript of the speech, sponsored by AstraZeneca and broadcast from Somerset Place, a Chicago nursing home.

Two years after the speech, the Food and Drug Administration, armed with mounting research, asked AstraZeneca to warn patients of Seroquel's diabetes risk. The drug's label now cautions that the medication is linked to diabetes and weight gain -- with nearly four times more patients gaining weight on Seroquel than on a placebo.

In his response to reporters, Reinstein characterized Seroquel as "generally weight neutral, although some patients gain weight and others lose weight."

"I would never recommend" that patients take antipsychotics "to lose weight," he wrote.

AstraZeneca spokesman Tony Jewell said plaintiffs have not proved that Seroquel was responsible for their injuries. He said the company, based in London, provided appropriate safety data about Seroquel to the FDA.

Chanile Hayes, who said she saw Reinstein during visits to his office, questioned why he prescribed her the drug: "How could you tell me that it would help me lose weight if it doesn't help (people) lose weight?"

At AstraZeneca, early doubtsIn the corporate halls of AstraZeneca, the company's scientific staff also questioned Reinstein's work.

I encourage everyone to go read both of these articles in entirety at the Chicago Tribune

_________________________________________________

For further reading and in-depth analysisplease check out these links below:

FAIR USE NOTICE: This may contain copyrighted (C) material the use of which has not always been specifically authorized by the copyright owner. Such material is made available for educational purposes, to advance understanding of human rights, democracy, scientific, moral, ethical, and social justice issues, etc. It is believed that this constitutes a 'fair use' of any such copyrighted material as provided for in Title 17 U.S.C. section 107 of the US Copyright Law. This material is distributed without profit.

Terms and conditions on the use of the contents of the “Is Something Not Quite Right with Stan - A Mental Health Blog” site are for informational and entertainment purposes only. Stan does not represent or guarantee the accuracy, completeness, timeliness or reliability of the information or content (collectively, the "Materials") contained on, distributed through, or linked, downloaded or accessed from this website.

Stan encourages you to make your own health care and legal decisions based upon your research and in partnership with a qualified health care and/ or legal professional. The information posted here should not be considered medical advice and is not intended to replace consultation with a qualified medical professional if they exist. I do not answer specific medical questions.

Third party information is gathered from sources that Stan believes to be reliable. However, in no event shall Stan, or any third parties mentioned on this site be liable for any damages resulting directly or indirectly from the use of the content whether or not Stan is advised of the possibility of such damages.

Stan reserves the right, in its sole discretion and without any obligation, to make improvements to, or correct any error or omissions in any portion of the displayed materials.

You hereby acknowledge that any reliance upon any Materials shall be at your sole risk.

Disclaimer of Liability

The user assumes all responsibility and risk for the use of this web site and the Internet generally. Under no circumstances, including negligence, shall anyone involved in creating or maintaining this web site, or shall the website writer or any commenter’s be liable for any direct, indirect, incidental, special or consequential damages, or lost profits that result from the use or inability to use the web site and/or any other web sites which are linked to this site.

Nor shall they be liable for any such damages including, but not limited to, reliance by a visitor on any information obtained via the web site; or that result from mistakes, omissions, interruptions, deletion of files, viruses, errors, defects, or any failure of performance, communications failure, theft, destruction or unauthorized access.

ALL CONTENT ON THIS WEB SITE IS PROVIDED TO YOU ON AN "AS IS," "AS AVAILABLE" BASIS WITHOUT WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND NON-INFRINGEMENT. Stan MAKES NO WARRANTY AS TO THE ACCURACY, COMPLETENESS, CURRENCY, OR RELIABILITY OF ANY CONTENT AVAILABLE THROUGH THIS WEB SITE.

In states which do not allow some or all of the above limitations of liability, liability shall be limited to the greatest extent allowed by law.

Disclaimer of Endorsement - Reference to any products, services, hypertext link to the third parties or other information by trade name, trademark, supplier or otherwise does not constitute or imply its endorsement, sponsorship or recommendation by me. Nor is an endorsement by me is implied by such links. They are for convenience only, as an index in a public library.

Information Subject to Change - Any information on this web site may be removed without notice. Information may include technical inaccuracies or typographical errors. Furthermore, the information may change from time to time without any notice.

GENERAL INFORMATION - The information contained in this online site is presented and intended to provide a broad understanding and knowledge critical to psychiatric practices and humorous social interaction. The information should not be considered complete and should not be used in place of communication and consultation.

NO WARRANTIES “Is Something Not Quite Right With Stan - A Mental Health Blog” MAKES NO REPRESENTATIONS OR WARRANTIES THAT USE OF THE WEB SITE WILL BE UNINTERRUPTED OR ERROR-FREE. YOU ARE RESPONSIBLE FOR TAKING ALL PRECAUTIONS NECESSARY TO ENSURE THAT ANY CONTENT YOU MAY OBTAIN FROM THE WEB SITE IS FREE OF VIRUSES.

This site is not a monologue of truth. It is a catalyst for public debate about medical conduct and for entertainment purposes. The reader is urged to confront officials to clarify issues mentioned herein. This site is designed strictly to provide information for critical, literary, academic, entertainment, and public usage. A qualified and trustworthy medical professional must be consulted regarding medical issues, treatments, diagnoses, etc.; if they exist in all actuality or truth.

Making a small bit of news in some high, and sometimes not so high places